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Why Are Children Needed for Clinical Trials?

The main purpose of clinical trials is to test the safety and efficacy of new treatments on people. Clinical trials reveal important information about new medical treatments. We can learn if a treatment works and if it is more effective than other treatments. We can also learn if these treatments have side effects, expected or otherwise.

These studies are intended to improve the quality of life and health care for people all over the world, even children. Without the use of clinical trials, we have no way of knowing how these treatments will work, if they carry risks, or if they are even effective.

These trials ensure that the appropriate dosage, use, and risks for children are known before a new treatment can go to market. However, child clinical studies are not conducted lightly or without care. The FDA has rigid guidelines to ensure the safety of any child participating in a clinical trial.

The purpose of this article is to delve into the reasons why children are needed for clinical trials, what the benefits and risks may be, and how they are conducted. After reading this, we hope you will be able to make a more informed decision about whether or not clinical trials are right for your child.

How Are Pediatric Clinical Trials Conducted?

How are these studies conducted? Any clinical trial is conducted according to a strict plan known as a protocol. The protocol for a given study lays out how the study will be performed, what study candidates to look for, and the estimated time it will take to complete the trial. Additionally, the protocol specifies what the study is testing for and how data will be gathered and recorded.

The purpose of a protocol is to make sure the study is conducted in a well thought out and professional manner. Above all else, a protocol is intended to eliminate as much risk as possible for participants in a clinical trial.

Following the protocols set, clinical trials are conducted using different phases. Each phase of a trial has different criteria and usually look to test different aspects of a treatment.

Phase 1

In the first phase of clinical trials, researchers are typically looking to test the safety of a treatment for human use. This phase usually consists of a small number of participants, often using healthy volunteers. All patients are usually given the treatment at this stage without the use of a control group.

Phase 2

During phase 2 research, studies begin to enroll a larger group of people for testing. The focus of this phase is to look for any side effects the treatment may have and see if the treatment yields desirable effects. While the safety of the treatment is still being tested during phase 2, the trials are not large enough to give any definitive answers about the treatment.

Phase 3

This phase are when trials begin to enroll a large number of participants. Phase 3 trials usually consist of hundreds to thousands of people taking part in the study. While testing for side effects on a larger scale, phase 3 trials also compare the effectiveness of treatments against already established treatments if possible.

This phase of study helps to really show the effectiveness, potential benefits, and possible adverse reactions associated with a new treatment. The majority of treatments that make it to phase 3 successfully make it to market and eventually to phase 4 testing.

Phase 4

The final stage of clinical testing occurs after a drug or treatment has been approved for consumer sale. Phase 4 trials look to test the long-term effects of a treatment, how the treatment compares to similar treatments already in market, and the cost-effectiveness of the treatment in the market.

Due to the nature of clinical trials, testing treatments for the first time, there are usually potential benefits and risks involved. Part of the reason for these studies is to look for risks or benefits that are unknown. The risks and benefits of your child participating in a study can include:

Potential Risks

Participation in a trial may lead to your child becoming ill or infected.

Potential Benefits

Your child may receive health care and medication free of charge.

Information gathered from your child’s participation may benefit others in the future.

Closer attention and monitoring from physicians may be given to your child.

You and your child may gain access to more information about their condition.

New drugs and treatments may be given to your child.

How Are Children Protected?

If you are thinking about enrolling your child in a clinical trial, you may be wondering how your child will be protected during a clinical trial. Fortunately, the safety and ethical treatment of clinical trial participants are guaranteed by federal laws. These laws put strict guidelines on how to conduct clinical trials and treat patients in a trial.

These safety checks involve:

Having an institutional review board (IRB) and scientific experts carefully analyze and give final approval of the study protocol.

Getting informed consent from any and all participants in a clinical trial.

The trial being monitored continuously by:

The sponsoring organization for the trial

The trial’s research team

The IRB

Data and Safety Monitoring Boards (DSMBs)

However, the informed consent process is a bit different for clinical trials involving children. Any person under the age of 18 is not legally allowed to give informed consent. First, for a child to participate in a study, both parents’ permission must be obtained. The permission of one parent may suffice in the case that one parent:

Is incapable of giving permission

Has passed away

Is not known

Is the sole legal guardian of the child

Once parental permission is obtained, assent from the child must be given. What is children’s assent? Children’s assent is agreement from the child that they understand and are willing to enroll in the study. A child may also give dissent or decline to be part of a study. Assent can only be obtained if the child is capable of understanding what the trial involves and what their role is.

Questions to Ask Before Joining a Clinical Trial

Before you agree to let your child take part in a clinical trial, there are a few questions you should consider asking:

What are the treatments and tests that will be administered during the study?

If there are changes in the study that might make us withdraw, will we be notified?

Who will be in charge of my child’s care?

What will happen if I want my child removed from the study?

Who will be able to see my child’s health information and how is their information kept private?

What costs can I expect in association with my child being part of the study?

How long will the trial last?

How much time is my child expected to spend at the study sites, hospital or clinic?

Who can I go to with questions before, during and after the trial?

Should You Enroll Your Child in a Study?

We understand that enrolling your child in a clinical trial can be a scary and difficult thing. It is not a decision that should be made lightly. If you are considering enrolling your child in a study, we encourage you to review this article and make sure you fully understand the possible benefits and risks involved.

Additionally, you should do some further research on your own regarding clinical trials for children. Once you have gathered all the information, you can make an informed decision on whether or not a clinical trial would be right for your child.

At Achieve Clinical Research, we take pride in our professional staff, state of the art facilities and expertly conducted studies, focused on the safety and well being of our patients. If you would like to know more about our upcoming children’s clinical trials or other studies, please visit our patient resource center, or call us at (205) 757-8208.